Investigation of VAP-1 Expression and Tissue Blood Flow by PET-MRI in Patients With Crohn's Disease (NCT06555042) | Clinical Trial Compass
RecruitingNot Applicable
Investigation of VAP-1 Expression and Tissue Blood Flow by PET-MRI in Patients With Crohn's Disease
Finland20 participantsStarted 2024-09
Plain-language summary
This is an observational, single center, imaging study. The CD patients with active disease will be assessed by \[68Ga\]Ga-DOTA-Siglec-9 and \[15O\]H2O PET/MRE. Patients with high clinical suspicion of small intestine's CD in outpatient gastroenterology clinic of Turku University Hospital will be recruited. The patients must fulfil the eligibility criteria and give their signed approvement prior to their enrolment into the study.
20 patients with high suspicion of active small bowels CD will be enrolled to being evaluated for potential participation in this study. In patients with diagnosed small bowels CD, PET-MRE will be repeated 3 months after the initial imaging (and based on clinical diagnostic started medication) to verify disease remission/inadequacy of the treatment.
Assessments for CD clinical disease activity will be performed at screening and \[68Ga\]Ga-DOTA-Siglec-9 and \[15O\]H2O PET/MRE assessments will be performed within a month for each patient.
After PET/MRE all patients can be treated according to patients' needs with immunosuppressive drugs. Follow-up visits are organized at after PET/MRE imaging at gastroenterology outpatient clinic.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults between age 18-70
* Strong clinical suspicion of small bowel Crohn's disease
* Able and willing to give written informed consent and to comply with the study protocol
Exclusion Criteria:
* Pregnant or breast-feeding women
* Previous capsule retention
* X-ray investigations during preceding year
* Patients with metallic implants such as an electronic pacemaker or an implanted infusion pump
* Known stenosis of the GI-tract
* Evidence of significant uncontrolled concomitant diseases such as neurological, renal, hepatic, endocrine, or gastrointestinal disorders which, in the opinion of the Investigator, would preclude patient participation
* Is unable or unwilling to comply with the study protocol for any reason
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
VAP-1 expression in the small bowel of patients with Crohn's disease